Effect of a Low Calorie Diet Containing Nuts on Systemic and Vascular Inflammation

May 17, 2020 updated by: Javad Nasrollahzadeh, Shahid Beheshti University

Effect of Low Calorie Diets With and Without Nuts on Systemic and Vascular Inflammation in Patients With Stable Coronary Artery Disease

Accumulating evidence from prospective observational studies and a large clinical trial suggests that nut intake lowers the risk of cardiovascular disease (CVD). Tree nuts are rich in unsaturated fats, soluble fiber, antioxidants, and phytosterols. The purpose of this study is to compare the effects of low calorie diets with a mixture of nuts in comparison with low calorie diets in improving inflammatory markers in patients with stable coronary artery disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized placebo controlled clinical trial will be conducted in modares hospital in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 66 eligible patients, aged 35-70 years. Intervention group will be received low calories diets as well as 20 percent of daily calories from mixed nuts (peanuts, pistachio and almond) and control group will be received low calories diets for 8 weeks. Fasting blood sample will be taken to measure inflammatory markers (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and C-Reactive Protein [CRP]).

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 19395-4741
        • Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus)
  • patients with coronary artery disease
  • willing to participation in the study

Exclusion Criteria:

  • َChronic kidney disease stage 3-5
  • Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Low calorie diets with nuts
Low calorie diet in which 20 percent of daily calories will be provided from nuts
Dietary supplement: Nut consumption
daily consumption of 20 percent of daily calories intake from nuts (pistachio, almond and peanuts)
Other Names:
  • Dietary Modification
Other: Low calorie diet
Low calorie diet
PLACEBO_COMPARATOR: Low calorie diet
Other: Low calorie diet
Low calorie diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C reactive protein (CRP)
Time Frame: 8 week
C reactive protein
8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammatory cytokines
Time Frame: 8 week
Change in plasma level of inflammatory cytokines
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University

Collaborators

Shahid Beheshti University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 18, 2019

Primary Completion (ACTUAL)

May 18, 2020

Study Completion (ACTUAL)

May 18, 2020

Study Registration Dates

First Submitted

August 31, 2019

First Submitted That Met QC Criteria

August 31, 2019

First Posted (ACTUAL)

September 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 17, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 890

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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